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Sr Manager, Regulatory Labeling and Ad Promo

Role overview

Qualifications

  • Bachelor's degree in a scientific discipline or related field
  • Minimum of 10 years of experience in regulatory affairs
  • Specific experience in labeling, ad promo and artwork within the pharmaceutical or biotechnology industry

Responsibilities

  • Provide regulatory guidance and assistance on labeling, ad promo and artwork related issues
  • Manage the creation, review, and approval of labeling documents, including new and revised prescribing information
  • Provide promotional regulatory input on concepts and draft materials
  • Review and approval of promotional materials for assigned products

Key facts

Other skills

  • Packaging And Labeling
  • Collaboration
  • Personal Integrity

About the company

ICON plc logo

ICON plc

Contract Research Organizations (CRO)

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

Senior Manager, Regulatory Strategy (Labeling & Ad Promo)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


At ICON, we are looking for a Senior Manager, Regulatory Labeling and Ad Promo who is passionate about making a meaningful impact across the pharmaceutical product lifecycle. In this role, you will support pre- and post-market label development and lifecycle maintenance, provide expert regulatory review of advertising and promotional materials, and contribute to artwork development that supports successful development, marketing applications, and implementation for drugs, devices, and combination products.

Location: US Remote

What You Will Do:

You will provide regulatory labeling and ad promo services, balancing quality, timelines, and stakeholder expectations.

Key responsibilities include:

  • Provide regulatory guidance and assistance to internal teams and external clients on labeling, ad promo and artwork related issues
  • Manage the creation, review, and approval of labeling documents, including new and revised prescribing information, patient information and packaging
  • Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with promotional regulations, corporate standards and policies and business objectives
  • Review and approval of promotional materials for assigned products and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines
  • Support artwork design (mock-ups, master/commercial/press ready, stability/validation), labeling/packaging components (leaflets, cartons, labels) and artwork review and QC (dieline, fonts, images)
  • Ensure compliance with regulatory requirements and standards related to labeling, ad promo and artwork
  • Builds and maintains strong collaborative relationships with key internal and external (client) stakeholders, including Global Regulatory leadership team, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion, Global Development, Legal, Manufacturing, Supply Chain and other functions key to the success of product development and commercialization

Your Profile:

You will have a strong background in regulatory affairs, with proven experience and a commitment to quality delivery.

Required qualifications and experience:

  • Bachelor's degree in a scientific discipline or related field
  • Minimum of 10 years of experience in regulatory affairs with specific experience in labeling, ad promo and artwork within the pharmaceutical or biotechnology industry

#LI-SB7

#LI-Remote


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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